Trial · NCT01629563
PGL4001 Efficacy Assessment in Reduction of Symptoms Due to Uterine Leiomyomata
NCT01629563, Phase 3, Completed, PregLem SA; results first posted 2019-09-04
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. PGL4001 Efficacy Assessment in Reduction of Symptoms Due to Uterine Leiomyomata. Trials, record NCT01629563. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01629563
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- PGL4001 Efficacy Assessment in Reduction of Symptoms Due to Uterine Leiomyomata
- NCT number
- NCT01629563
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 451 participants, actual
- Lead sponsor
- PregLem SA
- Conditions
- Uterine Fibroids
- Interventions
- PGL4001 5 mg, PGL4001 10 mg
- First posted
- 2012-06-27
- Last updated
- 2019-09-04
- Results first posted
- 2019-09-04
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Subjects Who Are in Amenorrhea at the End of All Four Treatment Courses | 18 months study duration per subject (4 3-month intermittent treatment courses) | Amenorrhoea was defined as no more than 1 day of spotting within a 35 day interval. Subjects need to be in amenorrhoea at the end of all four treatment courses, i.e for at least 4x35 days. |
| Secondary | Percentage of Subjects Who Were in Amenorrhea at the End of Treatment Course 4 | After 18 months | Amenorrhoea was defined as no more than 1 day of spotting within a 35 day interval. |
| Secondary | Percentage of Subjects With Controlled Bleeding at the End of All 4 Treatment Courses | After 18 months | Controlled bleeding was defined as no episodes of heavy bleeding and a maximum of 8 days of bleeding during the last 56 days of a treatment course. Subjects need to be in controlled bleeding at the end of all 4 treatment courses i.e. for at least 4x56 days. |
| Secondary | Percentage of Change From Baseline to End of Treatment Course 4 in the Total Volume of the 3 Largest Fibroids | After 18 months | For the 3 largest myomas at baseline and the 3 largest myomas at the end of treatment course 4 identified by transvaginal ultrasound, length, height and depth were measured and the volume was estimated by applying the equation for the voulme of an ellipsoid (length x height x depht x π/6). Subjects were exposed to 4 3-month intermittent courses. |
| Secondary | Percentage of Change From Baseline to End of Treatment Course 4 in Quality of Life (Uterine Fibroid Symptom Severity (UFSQoL) | After 18 months | Quality of Life was assessed using a validated questionnaire measuring uterine fibroid symptom severity (UFSQoL) where lower scores indicate fewer symtoms and where a level of 23 has been reported for healthy subject (scale 0-100). Subjects were exposed to 4 3-month intermittent courses. |
| Secondary | Percentage of Change From Baseline to End of Treatment Course 4 in Quality of Life -Uterine Fibroid Health Related Quality of Life (HRQL) | 18 months | Quality of Life was measured using a validated uterine fibroid symptom questionnaire. Total score for health related quality of Life (HRQL) range from 0 to 100 with higher scores indicating better Quality of Life. Subjects were exposed to 4 3-month intermittent courses. |
| Secondary | Percentage of Change From Baseline to End of Treatment Course 4 in Pain Using a Visual Analogue Scale (VAS) | After 18 months | Pain was assessed using a Visual Analogue Scale (VAS) ranging from 0 to 100 with higher score indicating more severe pain. Subjects were exposed to 4 3-month intermittent courses. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Subjects Who Are in Amenorrhea at the End of All Four Treatment Courses | 18 months study duration per subject (4 3-month intermittent treatment courses) | Full Analysis Set 1 (subjects who received study treatment at least once for treatment course 1) (subjects with missing values were excluded from analysis) | percentage of subjects | NUMBER |
| SECONDARY | Percentage of Subjects Who Were in Amenorrhea at the End of Treatment Course 4 | After 18 months | Full Analysis Set 1 (all subjects who received study treatment once for treatment course 1) (subjects with missing values were excluded from analysis) | percentage of participants | NUMBER |
| SECONDARY | Percentage of Subjects With Controlled Bleeding at the End of All 4 Treatment Courses | After 18 months | Full analysis set 1 (all subject who received study treatment at least once for treatment course 1) (subjects with missing values were excluded from analysis) | percentage of participants | NUMBER |
| SECONDARY | Percentage of Change From Baseline to End of Treatment Course 4 in the Total Volume of the 3 Largest Fibroids | After 18 months | Full Analysis Set 1 (all subjects who received study treatment at least once for treatment course 1) (subjects with missing values were excluded from analysis) | percentage of change from baseline | MEDIAN |
| SECONDARY | Percentage of Change From Baseline to End of Treatment Course 4 in Quality of Life (Uterine Fibroid Symptom Severity (UFSQoL) | After 18 months | Full Analysis Set 1 (all subjects who received study treatment at least once for treatment course 1) (subjects with missing values were excluded from analysis) | percentage of change from baseline | MEDIAN |
| SECONDARY | Percentage of Change From Baseline to End of Treatment Course 4 in Quality of Life -Uterine Fibroid Health Related Quality of Life (HRQL) | 18 months | Full Analysis Set 1 (all subjects who received study treatment at least once for treatment course 1) (subjects with missing values were excluded from analysis) | percentage of change from baseline | MEDIAN |
| SECONDARY | Percentage of Change From Baseline to End of Treatment Course 4 in Pain Using a Visual Analogue Scale (VAS) | After 18 months | FAS1 (all subjects who received study treatment at least once for treatment course 1) (subjects with missing values were excluded from analysis) | percentage of change from baseline | MEDIAN |
Source ClinicalTrials.gov
Results by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Subjects Who Are in Amenorrhea at the End of All Four Treatment Courses | Ulipristal Acetate (PGL4001) 5mg | 48.7 | percentage of subjects | ||
| Percentage of Subjects Who Are in Amenorrhea at the End of All Four Treatment Courses | Ulipristal Acetate (PGL4001) 10mg | 60.5 | percentage of subjects | ||
| Percentage of Subjects Who Were in Amenorrhea at the End of Treatment Course 4 | Ulipristal Acetate (PGL4001) 5mg | 69.6 | percentage of participants | ||
| Percentage of Subjects Who Were in Amenorrhea at the End of Treatment Course 4 | Ulipristal Acetate (PGL4001) 10mg | 74.5 | percentage of participants | ||
| Percentage of Subjects With Controlled Bleeding at the End of All 4 Treatment Courses | Ulipristal Acetate (PGL4001) 5mg | 67.1 | percentage of participants | ||
| Percentage of Subjects With Controlled Bleeding at the End of All 4 Treatment Courses | Ulipristal Acetate (PGL4001) 10mg | 71.9 | percentage of participants | ||
| Percentage of Change From Baseline to End of Treatment Course 4 in the Total Volume of the 3 Largest Fibroids | Ulipristal Acetate (PGL4001) 5mg | -67.0 | Inter-Quartile Range -85.6 to -35.1 | percentage of change from baseline | |
| Percentage of Change From Baseline to End of Treatment Course 4 in the Total Volume of the 3 Largest Fibroids | Ulipristal Acetate (PGL4001) 10mg | -70.4 | Inter-Quartile Range -88.0 to -41.7 | percentage of change from baseline | |
| Percentage of Change From Baseline to End of Treatment Course 4 in Quality of Life (Uterine Fibroid Symptom Severity (UFSQoL) | Ulipristal Acetate (PGL4001) 5mg | -31.25 | Inter-Quartile Range -46.88 to -12.50 | percentage of change from baseline | |
| Percentage of Change From Baseline to End of Treatment Course 4 in Quality of Life (Uterine Fibroid Symptom Severity (UFSQoL) | Ulipristal Acetate (PGL4001) 10mg | -28.13 | Inter-Quartile Range -43.75 to -18.75 | percentage of change from baseline |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow14
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Ulipristal Acetate (PGL4001) 5mg | 228 | |
| Overall Study | STARTED | Ulipristal Acetate (PGL4001) 10mg | 223 | |
| Overall Study | Safety Population | Ulipristal Acetate (PGL4001) 5mg | 230 | |
| Overall Study | Safety Population | Ulipristal Acetate (PGL4001) 10mg | 221 | |
| Overall Study | Started Treatment Course 2 | Ulipristal Acetate (PGL4001) 5mg | 213 | |
| Overall Study | Started Treatment Course 2 | Ulipristal Acetate (PGL4001) 10mg | 207 | |
| Overall Study | Started Treatment Course 3 | Ulipristal Acetate (PGL4001) 5mg | 191 | |
| Overall Study | Started Treatment Course 3 | Ulipristal Acetate (PGL4001) 10mg | 190 | |
| Overall Study | Started Treatment Course 4 | Ulipristal Acetate (PGL4001) 5mg | 178 | |
| Overall Study | Started Treatment Course 4 | Ulipristal Acetate (PGL4001) 10mg | 176 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 participant flowAdverse events90
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | headache | Nervous system disorders | Ulipristal Acetate (PGL4001) 5mg | 31 | 230 | |
| other | headache | Nervous system disorders | Ulipristal Acetate (PGL4001) 10mg | 30 | 221 | |
| other | hot flush | Reproductive system and breast disorders | Ulipristal Acetate (PGL4001) 5mg | 18 | 230 | |
| other | hot flush | Reproductive system and breast disorders | Ulipristal Acetate (PGL4001) 10mg | 23 | 221 | |
| other | influenza | Infections and infestations | Ulipristal Acetate (PGL4001) 5mg | 12 | 230 | |
| other | influenza | Infections and infestations | Ulipristal Acetate (PGL4001) 10mg | 10 | 221 | |
| other | nasopharyngitis | Infections and infestations | Ulipristal Acetate (PGL4001) 5mg | 7 | 230 | |
| other | nasopharyngitis | Infections and infestations | Ulipristal Acetate (PGL4001) 10mg | 12 | 221 | |
| other | breast pain/breast tenderness/breast disconfort | Reproductive system and breast disorders | Ulipristal Acetate (PGL4001) 5mg | 10 | 230 | |
| other | breast pain/breast tenderness/breast disconfort | Reproductive system and breast disorders | Ulipristal Acetate (PGL4001) 10mg | 8 | 221 |
1 to 10 of 90Source ClinicalTrials.gov
See all 90 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ulipristal Acetate (PGL4001) 5mg | ||
| Total, all-cause mortality | Ulipristal Acetate (PGL4001) 10mg | ||
| Total, other adverse events | Ulipristal Acetate (PGL4001) 5mg | 129 | 230 |
| Total, other adverse events | Ulipristal Acetate (PGL4001) 10mg | 131 | 221 |
| Total, serious adverse events | Ulipristal Acetate (PGL4001) 5mg | 16 | 230 |
| Total, serious adverse events | Ulipristal Acetate (PGL4001) 10mg | 12 | 221 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Ulipristal Acetate (PGL4001) 5mg vs Ulipristal Acetate (PGL4001) 10mg: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01629563
GET https://conductscience.org/api/trials/v1/NCT01629563/events?page=2